Adverse Reaction Profile

TORISEL—established tolerability profile in poor-risk patients
 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

Adverse reactions (ARs)

Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had =3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly).
 
*Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
lncludes edema, facial edema, and peripheral edema.
lncludes aphthous stomatitis, glossitis, mouth ulceration, mucositis, and stomatitis.
§lncludes infections not otherwise specified (NOS) and the following infections that occurred infrequently as distinct entities: abscess, bronchitis, cellulitis, herpes simplex, and herpes zoster.
llIncludes cystitis, dysuria, hematuria, urinary frequency, and urinary tract infection.
lncludes eczema, exfoliative dermatitis, maculopapular rash, pruritic rash, pustular rash, rash (NOS), and vesiculobullous rash.
#lncludes taste loss and taste perversion.
 
 
 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

Laboratory abnormalities

Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had =3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly).
*CTCAE, version 3.0.
Grade 1 toxicity may be underreported for lymphocytes and neutrophils.

View additional Important Safety Information.
 
 
 

In the phase 3 Global ARCC study of TORISEL vs IFNa…

Discontinuation rates

The majority (93%) of patients did not discontinue TORISEL due to ARs2

Results from a phase 3, multicenter, randomized, open-label study in previously untreated patients with advanced RCC who had =3 of 6 preselected prognostic risk factors. Patients received TORISEL (n=209, 25 mg IV once weekly) or IFNa (n=207, maximum 18 MU SubC 3 times weekly).
  • Additional reasons for discontinuation of TORISEL or IFNa, respectively, included symptomatic deterioration (6.7% vs 14.0%), patient request (3.8% vs 3.0%), death (2.9% vs 5.0%), other (1.0% vs 2.0%), protocol violation (0.5% vs 1.0%), and disease progression (73.6% vs 57.5%)1,2
  • 65.9% of patients on TORISEL had dose delays vs 67.5% with IFNa2
  • 23.1% of patients on TORISEL had dose reductions vs 39.0% with IFNa2
 

REFERENCES
  1. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-2281.
  2. Data on file. Pfizer Inc, New York, NY.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.3.2015. © National Comprehensive Cancer Network, Inc 2014. All rights reserved. Accessed January 13, 2015. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.